MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 15MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS40150C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia Stroke (4418); Paresthesia (4421)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported during a clinical study that after implant of the stent (subject device) on (b)(6) 2016 to treat aneurysm located at the left middle cerebral artery-m1, the patient suffered right arm and leg tingling / paresthesia's adjudicated as a minor ischemic stroke per cec within the same month of procedure.The patient was given heparin 7000 iu and treatment is ongoing.No other information is available.

Event Description

It was reported during a clinical study that after implant of the stent (subject device) on (b)(6) 2016 to treat aneurysm located at the left middle cerebral artery-m1, the patient suffered right arm and leg tingling / paresthesia's adjudicated as a minor ischemic stroke per cec within the same month of procedure.The patient was given heparin 7000 iu and treatment is ongoing.No other information is available.

Manufacturer Narrative

Expiration date (d4) ¿ updated.Manufacturing date (h4)- updated.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes/dhr system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.H3 other text : device remains implanted in patient.

• Brand Name: NEUROFORM ATLAS 4.0MM X 15MM NO TIP- IDE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12740045
• MDR Text Key: 279680369
• Report Number: 3008881809-2021-00460
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: M003SZAS40150C
• Device Lot Number: 18428948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American